Mechanical Neck PainNCT04173143

Cranio- Cervical Flexion Training With and Without Pressure Biofeedback in Mechanical Neck Pain

A study testing Craniocervical flexion training with pressure biofeedback and Craniocervical flexion training without pressure biofeedback in people with Mechanical Neck Pain, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 40 years
Conditions the study is for: Mechanical Neck Pain
What is being tested?: Craniocervical flexion training with pressure biofeedback and Craniocervical flexion training without pressure biofeedback
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 sitePakistan
Study dates: 15 May 2019to 31 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

• Patients with Chronic mechanical neck pain for more than 3 months duration
subjects with aged 25-40 years
Numeric pain rating scale (NRPS) greater than 3.
Patients with Forward neck posture and a Craniovertebral angle less than 48°

Who cannot join

• History of neck surgery, cervical trauma Spinal cord compression, Spinal tumor, Spinal instability
History of Spinal fracture, inflammatory disease of spine, Spinal infections, significant neurological deficit, Congenital or acquired postural deformity, doing prescribed exercise for cervical spine.
Neck or shoulder pain from non-musculoskeletal causes, demonstrated neurological signs, or had a history of malignancy, current pregnancy.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Pakistan Railway hospital
Rawalpindi, Punjab Province, 40100

Other trials in Pakistan

About this study

Official title: Effects of Cranio- Cervical Flexion Training With and Without Pressure Biofeedback in Patients With Mechanical Neck Pain

The superficial neck flexor musculature has been given considerate amount of attention to explore its effects on the cervical pain in several researches.. This study intends to put through the benefits of deep cervical flexor training for treatment of cervical neck pain patients.This study will also compare the effects of Cranio cervical flexion training with and without pressure biofeedback on neck pain, muscular endurance,forward head posture and cervical mobility in mechanical neck pain.

Read the detailed description

The study is Randomized Control Trail, which is being conducted in physical therapy Outpatient department of Pakistan Railway hospital. Sample size of 24 individual was calculated using Epitool with 95% confidence interval (CI) and power 80%. Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups, 12 in Craniocervical flexion training with pressure biofeedbackgroup and 12 in Craniocervical flexion training without pressure biofeedbackgroup by sealed envelope method.

Deep neck flexor endurance techniquewas used totrain theCraniocervical flexor muscles in control group.Craniocervical flexion technique with Pressure biofeedback unit's was positioned behind the neck just below the occiput was used to train the endurance of the Craniocervical flexor muscle in experimental group.

Assessment will be done on baseline and 4th week. Data will be analyzed on SPSS version 21.

Conditions: Mechanical Neck Pain
Being tested: Craniocervical flexion training with pressure biofeedback, Craniocervical flexion training without pressure biofeedback
Keywords: endurance training,

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Craniocervical flexion training with pressure biofeedbackDevice
Total 15 patients participated in this training group. Session was performed thrice in a week. Each session was givenfor approximately 20minutesPatients were asked to lie in supine hook lying position. After that Pressure biofeedback unit's air bag was clipped together and folded in three and positioned behind the neck just below the occiput. Patients were advised to perform Craniocervical flexion and practiced head nodding action to progressively target (reach the incremental targets) and hold the 5 pressure levels for 10 second between 22 mm Hg and 30 mmHg. A 2 minute second rest period was provided between each level. Minimum performance requirement was 26 mm Hg while ideal performance targets are 28 and 30 mm Hg... Patient will be re-assessed for all baseline variables after 4 weeks of training
Craniocervical flexion training without pressure biofeedbackOther
Total 15 patients participated in this control group.Session was given 3 times in a week. Each session continue forapproximately 20 minutes. The patient lies in supine crook lying position. The patientwas maximally retracted the chin and asked to maintained it while the patient lifts the head and neck until the head is relatively 2 to 5 cm (1 inch) abovethe couch. The examiner places a hand under the head of patient on the table. Patients were instructed to perform10 repetitions for a hold of 20 seconds initially, increasing it by 10 seconds progressively.The entire session had a maximum of 4 sets. Patient will be re-assessed for all baseline variables after 4 weeks of training

Study groups in NCT04173143
Study group	Role	What they receive
Group 1	Experimental	This group will receive Cranio cervical flexion training with pressure biofeedback protocol. Receives: Device: Craniocervical flexion training with pressure biofeedback
Group 2	Active comparator	This group will receive Cranio cervical flexion training without pressure biofeedback protocol Receives: Other: Craniocervical flexion training without pressure biofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Measured: Baseline
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Measured: Post 4 week
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Measured: Post 6 week
CROM-Flexion
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Measured: Baseline
CROM-Flexion
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Measured: Post 4 week
CROM-Flexion
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Measured: Post 6th Week
CROM-Extention
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Measured: Baseline
CROM-Extention
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Measured: Post 4th Week
CROM-Extention
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Measured: Post 6th Week
Deep neck Flexor endurance
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Measured: Baseline
Deep neck Flexor endurance
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Measured: Post 4th Week
Deep neck Flexor endurance
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Measured: Post 6th Week
Craniocervical flexion test (Clinical test of endurance for experimental group)
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.
Measured: Baseline
Craniocervical flexion test (Clinical test of endurance for experimental group)
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.
Measured: Post 4th week
Craniocervical flexion test (Clinical test of endurance for experimental group)
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.
Measured: Post 6th week

Secondary outcomes (3)

Cranio-vertebral angle
On protractor tool was used to measure forward head posture through a craniovertebral angle (CVA).. It has excellent reliability value (ICC 0.991).Participants were asked to sit on a stool and concentrate at a specific point on their eye level.Then we used three markers: one on C7, the other on tragus and the third on canthus. The angle between the line connecting C7 to tragus and a vertical line extending from C7 was calculated and images were taken. Patients having a Craniovertebral angle less than 48°were considered in category of forward head posture.
Measured: Baseline
Cranio-vertebral angle
On protractor tool was used to measure forward head posture through a craniovertebral angle (CVA).. It has excellent reliability value (ICC 0.991).Participants were asked to sit on a stool and concentrate at a specific point on their eye level.Then we used three markers: one on C7, the other on tragus and the third on canthus. The angle between the line connecting C7 to tragus and a vertical line extending from C7 was calculated and images were taken. Patients having a Craniovertebral angle less than 48°were considered in category of forward head posture.
Measured: Post 4th week
Cranio-vertebral angle
On protractor tool was used to measure forward head posture through a craniovertebral angle (CVA).. It has excellent reliability value (ICC 0.991).Participants were asked to sit on a stool and concentrate at a specific point on their eye level.Then we used three markers: one on C7, the other on tragus and the third on canthus. The angle between the line connecting C7 to tragus and a vertical line extending from C7 was calculated and images were taken. Patients having a Craniovertebral angle less than 48°were considered in category of forward head posture.
Measured: Post 6th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 201931 Dec 2019

First posted21 Nov 2019
Study start15 May 2019
Primary completion15 Dec 2019
Study completion31 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Mechanical Neck PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Both experimental and control groups will be treated simultaneously with different modes of endurance training
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04173143
Sponsor's protocol ID: RiphahIU Rabia Ashfaq
Status last verified: Jan 2020
First submitted: 20 Nov 2019
Last updated: 22 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gupta BD, Aggarwal S, Gupta B, Gupta M, Gupta N. Effect of Deep Cervical Flexor Training vs. Conventional Isometric Training on Forward Head Posture, Pain, Neck Disability Index In Dentists Suffering from Chronic Neck Pain. J Clin Diagn Res. 2013 Oct;7(10):2261-4. doi: 10.7860/JCDR/2013/6072.3487. Epub 2013 Oct 5.
PubMed 24298492
Kim JY, Kwag KI. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain. J Phys Ther Sci. 2016 Jan;28(1):269-73. doi: 10.1589/jpts.28.269. Epub 2016 Jan 30.
PubMed 26957772
Kang DY. Deep cervical flexor training with a pressure biofeedback unit is an effective method for maintaining neck mobility and muscular endurance in college students with forward head posture. J Phys Ther Sci. 2015 Oct;27(10):3207-10. doi: 10.1589/jpts.27.3207. Epub 2015 Oct 30.
PubMed 26644676
Iqbal ZA, Rajan R, Khan SA, Alghadir AH. Effect of deep cervical flexor muscles training using pressure biofeedback on pain and disability of school teachers with neck pain. J Phys Ther Sci. 2013 Jun;25(6):657-61. doi: 10.1589/jpts.25.657. Epub 2013 Jul 23.
PubMed 24259822
Suvarnnato T, Puntumetakul R, Uthaikhup S, Boucaut R. Effect of specific deep cervical muscle exercises on functional disability, pain intensity, craniovertebral angle, and neck-muscle strength in chronic mechanical neck pain: a randomized controlled trial. J Pain Res. 2019 Mar 7;12:915-925. doi: 10.2147/JPR.S190125. eCollection 2019.
PubMed 30881101

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Cranio- Cervical Flexion Training With and Without Pressure Biofeedback in Patients With Mechanical Neck Pain
ClinicalTrials.gov ID: NCT04173143
Acronym / sponsor ID: RiphahIU Rabia Ashfaq
Conditions: Mechanical Neck Pain
Keywords: endurance training,
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Riphah International UniversityUniversity, hospital or other
Study start: 15 May 2019 (actual)
Primary completion: 15 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 21 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Assessment will be done on baseline and 4th week. Data will be analyzed on SPSS version 21.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Both experimental and control groups will be treated simultaneously with different modes of endurance training

Arm	Type	Receives
Group 1	Experimental	Device: Craniocervical flexion training with pressure biofeedbackThis group will receive Cranio cervical flexion training with pressure biofeedback protocol.
Group 2	Active comparator	Other: Craniocervical flexion training without pressure biofeedbackThis group will receive Cranio cervical flexion training without pressure biofeedback protocol

Who may qualify

Ages: 25 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

• Patients with Chronic mechanical neck pain for more than 3 months duration

Key exclusion criteria (3 listed)

• History of neck surgery, cervical trauma Spinal cord compression, Spinal tumor, Spinal instability

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Craniocervical flexion training with pressure biofeedbackTotal 15 patients participated in this training group. Session was performed thrice in a week. Each session was givenfor approximately 20minutesPatients were asked to lie in supine hook lying position. After that Pressure biofeedback unit's air bag was clipped together and folded in three and positioned behind the neck just below the occiput. Patients were advised to perform Craniocervical flexion and practiced head nodding action to progressively target (reach the incremental targets) and hold the 5 pressure levels for 10 second between 22 mm Hg and 30 mmHg. A 2 minute second rest period was provided between each level. Minimum performance requirement was 26 mm Hg while ideal performance targets are 28 and 30 mm Hg... Patient will be re-assessed for all baseline variables after 4 weeks of training	Device	Group 1
Craniocervical flexion training without pressure biofeedbackTotal 15 patients participated in this control group.Session was given 3 times in a week. Each session continue forapproximately 20 minutes. The patient lies in supine crook lying position. The patientwas maximally retracted the chin and asked to maintained it while the patient lifts the head and neck until the head is relatively 2 to 5 cm (1 inch) abovethe couch. The examiner places a hand under the head of patient on the table. Patients were instructed to perform10 repetitions for a hold of 20 seconds initially, increasing it by 10 seconds progressively.The entire session had a maximum of 4 sets. Patient will be re-assessed for all baseline variables after 4 weeks of training	Other	Group 2

Primary outcome

Numeric pain rating scale (NPRS)
Time frame: Baseline
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Numeric pain rating scale (NPRS)
Time frame: Post 4 week
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Numeric pain rating scale (NPRS)
Time frame: Post 6 week
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
CROM-Flexion
Time frame: Baseline
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
CROM-Flexion
Time frame: Post 4 week
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
CROM-Flexion
Time frame: Post 6th Week
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
CROM-Extention
Time frame: Baseline
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
CROM-Extention
Time frame: Post 4th Week
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
CROM-Extention
Time frame: Post 6th Week
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Deep neck Flexor endurance
Time frame: Baseline
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Deep neck Flexor endurance
Time frame: Post 4th Week
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Deep neck Flexor endurance
Time frame: Post 6th Week
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Craniocervical flexion test (Clinical test of endurance for experimental group)
Time frame: Baseline
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.
Craniocervical flexion test (Clinical test of endurance for experimental group)
Time frame: Post 4th week
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.
Craniocervical flexion test (Clinical test of endurance for experimental group)
Time frame: Post 6th week
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.

3 secondary outcomes

Cranio-vertebral angle
Time frame: Baseline
Cranio-vertebral angle
Time frame: Post 4th week
Cranio-vertebral angle
Time frame: Post 6th week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
Background: PubMed 24298492Gupta BD, Aggarwal S, Gupta B, Gupta M, Gupta N. Effect of Deep Cervical Flexor Training vs. Conventional Isometric Training on Forward Head Posture, Pain, Neck Disability Index In Dentists Suffering from Chronic Neck Pain. J Clin Diagn Res. 2013 Oct;7(10):2261-4. doi: 10.7860/JCDR/2013/6072.3487. Epub 2013 Oct 5.
Background: PubMed 26957772Kim JY, Kwag KI. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain. J Phys Ther Sci. 2016 Jan;28(1):269-73. doi: 10.1589/jpts.28.269. Epub 2016 Jan 30.
Background: PubMed 26644676Kang DY. Deep cervical flexor training with a pressure biofeedback unit is an effective method for maintaining neck mobility and muscular endurance in college students with forward head posture. J Phys Ther Sci. 2015 Oct;27(10):3207-10. doi: 10.1589/jpts.27.3207. Epub 2015 Oct 30.
Background: PubMed 24259822Iqbal ZA, Rajan R, Khan SA, Alghadir AH. Effect of deep cervical flexor muscles training using pressure biofeedback on pain and disability of school teachers with neck pain. J Phys Ther Sci. 2013 Jun;25(6):657-61. doi: 10.1589/jpts.25.657. Epub 2013 Jul 23.
Background: PubMed 30881101Suvarnnato T, Puntumetakul R, Uthaikhup S, Boucaut R. Effect of specific deep cervical muscle exercises on functional disability, pain intensity, craniovertebral angle, and neck-muscle strength in chronic mechanical neck pain: a randomized controlled trial. J Pain Res. 2019 Mar 7;12:915-925. doi: 10.2147/JPR.S190125. eCollection 2019.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Huma Riaz, PHD* principal investigator

Riphah International University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric pain rating scale (NPRS) (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04173143, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.